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Sterilisation Equipment, Characteristics -VALIDATION
Günter DotterThursday, 26 March 2009, Opatija
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2 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Solutions for Cleaning, Disinfection and Sterilization in Healthcare, the Pharmaceutical Industry and Laboratories
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3 WFHSS | March 2009 | Günter Dotter |
� Regulatory Requirements
� Measuring Equipment
� Premises and conditions
� Application - Sequence
� Summary
Sterilisation Equipment – Characteristics
VALIDATION
OVERVIEW –Main criteria:
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4 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Regulatory Requirements –within the EU
� MDD, (Medical Device Directive) under directive 93/42 /EEC.
� EN 554
� EN ISO 17665 Part 1 + 2
� EN ISO 14937
� Regulations from national institutions, RKI*, Swissme dic,
� Recommendations from professional associations and societies
* Robert Koch Institute, Berlin, Germany
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5 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Regulatory Requirements –EN 554 / EN ISO 17665 Part 1 + 2 and EN ISO 14937
� Requirements according the EN:
Sterilisation of products and devices for the health c are. General requirements of the characteristics of the steril ant agent and of the development, validation and monito ring on a routine basis of a sterilization process for med ical products.
� The method is based on the monitoring of the physica l parameters i.e. (time, temperature and pressure), which are required to produce sterile products.
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6 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Regulatory Requirements –Personal qualification (EN 554)(EN 554)
Only qualified personnel can
be responsible for:
� Installation and preventative maintenance
� Validation and routine monitoring
� Release of sterile products
� I.e. Certified and authorized Validation specialist
� Certified according EN ISO 9001:2000
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7 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Regulatory Requirements -Reference literature
� ISO-10012-1: Quality requirements for Measuring systems
Measuring failure, less than 3-10 times, as the required measuring accuracy
� EN-554 Sterilisation of medical products
Measuring equipment should have 3 times higher measuring accuracy than measured reference point
� EN-285 Sterilisation – Steam sterilization – Large sterilizers
Failure between 0°C and 150°C, should not exceed + 0.25%
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8 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Overview
1. Temperature Reference2. Temperature Standard3. PC + Validation Software4. Chamber connection – validation5. Data Logger + Interface 6. Pressure Standard – Calibration
1 2 3
4 5
6
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9 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Complete System with Thermo elements
� Validator – Data recorder
� Temperature reference
� Temperature standard
� Thermo elements
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10 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Complete system with Thermo elements
� Temperature reference
� Measuring system
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11 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Complete system with Data loggers
Data loggers
� Temperature
� Temperature + pressure
� Interface + PC
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12 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Selection – Data recording sensors
Logger TC’s� Empty Chamber profile X X� Penetration study (hollow tubes) ���� X� ETO sterilizers (thermal) X ����
� Without Validation port X ����
� Online data ���� X� Multiple measuring points X X� Routine control / less measuring points X X� Surface temperatures ���� X� Rapid temperature changes ���� X
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13 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Norm – Test packs
� Bowie Dick – Test pack
� Bowie Dick – Test sheet
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14 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Balance
According EN 285
� Max. weight 25 kg
� Tolerance < + 0.001 kg
� Calibrated
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15 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Measuring Equipment –Documents – Test report
Binder with documents according
EN 554 / EN ISO 17665 Part 1+2
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16 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Example: System with thermo elements
Single steps for the qualification of an autoclave:
� Calibration of the thermo elements – determine tolerances and adjust
� Perform necessary test runs
� Evaluation of the calibration – calibration without adjustments
� Documentation and evaluation
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17 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Recorder with thermo elements
Influence of the measuring accuracy are:
Measuring system:
� Measuring writer
� Sensors (Thermo elements)
Calibration system:
� Temperature reference
� Temperature standard
� Human errors
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18 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Pressure test (EN 554 / EN ISO 17665 Part 1+2 / EN 285)
Testing the steam quality
� Correlation between Temperature and pressure
� Compare measured value with calculated value from the steam pressure scale
Types of sensors and calibration
� Online pressure sensors with fix connection
� Data logger (pressure) data evaluation after process
� Pressure calibration
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19 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Failure source - human
� The calibration procedure itself can cause measuring
failures. In case of calibration devices which are n ot
operate fully automatically, the user is responsible t o
control the stability of the measuring standards and a lso
the sensors.
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20 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Calibration system: Reference temperature
Main failure: Transfer calibration failure, Influenced by:
�� Thermal transitionThermal transition
�� Temperature distribution within des block / bathTemperature distribution within des block / bath
�� Depth of immersionDepth of immersion
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21 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Calibration system: Temperature standard
� All measuring procedures shall be defined on a nationa l or international standard (ISO-120012-1)
� The standard temperature should be therefore calibrate d, by a certified institution. (i.e. DKD Laboratory of calibration for temperature).
� The measured tolerance of the standard temperature should be declared at the calibration certificate.
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22 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Responsibilities
Belimed
� Preparation of the validation plan
� Measuring defined values
� Documentation of the performed measurement
Customer
� Release of the validation plan
� Provide media supply according DIN
� Define load of sterile goods
� Release of the validation report
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23 WFHSS | March 2009 | Günter Dotter |
(IQ(IQ))
(OQ)(OQ)
Sterilisation Equipment – Characteristics
VALIDATION
Premises and conditions –Sequence of the validation procedure
� Installation Qualification (IQ)
� Operational Qualification (OQ)
� Performance Qualification (PQ)
(PQ)(PQ)
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24 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Application - Sequence
1. Warm up & leak test
2. B & D test
3. Calibration & adjustment of process relevant compone nts
4. Empty chamber profile
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25 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Application –Empty chamber profileApplication - Sequence
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26 WFHSS | March 2009 | Günter Dotter |
Identification:Identification:
�� Handbook� Papers – pressure vessel� Software version PLC/PC� Program parameter
Media supply:Media supply:�� Steam� Air pressure� Cold water� DI / WFI / WBI water
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequenceInstallation Qualification (IQ)
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27 WFHSS | March 2009 | Günter Dotter |
� Calibration - sterilizer
� Calibration – measuring probes
� Vacuum test (VPR)
� Steam diffusion test (B&D)
� Empty chamber profile
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequenceOperation Qualification (OQ)
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28 WFHSS | March 2009 | Günter Dotter |
� Customized loading of sterilization batch cards
� Reference loading are measured (electro- thermal) and documented
� Microbiological evaluation
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequencePerformance Qualification (PQ)
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29 WFHSS | March 2009 | Günter Dotter |
� After – sterilization process
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequenceTest – residual moist
� Before – sterilization process
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30 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequenceVisual Test – residual moist
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31 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequenceDocumentation
� Validation report which is clearly arranged and contains all relevant data
� Comprehensive and precise measuring protocols and calculations
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32 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Application - SequenceRelease – Documentation through customer
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33 WFHSS | March 2009 | Günter Dotter |
Sterilisation Equipment – Characteristics
VALIDATION
Summary –Customer benefit
� Safe sterilization processes (Cleaning, Sterilisation , Packaging)
� High standard and consistent quality of the processe d medical products
� Competence about actual norms and regulations.
� Analysis of the loading structure
� Optimized process procedure within the CSSD
� Transparent costs and potential of costs savings.
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34 WFHSS | March 2009 | Günter Dotter |
Thank you for your attention
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